Name: Predicase
Price: 199 USD

K-number	K142956
Device name	NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit
Applicant	Integrated Healing Technologies
Product code	OMP
Device class	Class II
Decision date	Feb 24, 2015
Decision	Substantially Equivalent
Regulation	878.4780

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Source

View the full FDA submission: accessdata.fda.gov

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NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit

Everything you need for a 510(k) submission. Nothing you don't.